Petition for Inter Partes Review
`of U.S. Patent No. 6,631,715
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CORPAK MEDSYSTEMS, INC. and HALYARD HEALTH, INC,
`Petitioners
`
`v .
`
`APPLIED MEDICAL TECHNOLOGY, INC.,
`Patent Owner.
`
`U.S. Patent No. 6,631,715 to Kirn
`
`Inter Partes Review No.: IPR2017-00646
`
`Petition for Inter Partes Review of U.S. Patent No. 6,631,715 Under
`35 U.S.C. §§ 311-319 and 37 C.F.R. § 42
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`CORPAK Ex 1014, Page 1
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`

`

`TABLE OF CONTENTS
`
`I.
`II.
`
`III.
`
`C.
`
`V.
`
`VI.
`
`Page(s)
`INTRODUCTION.........................................................................................1
`OVERVIEW..................................................................................................1
`A.
`Description of the ʼ715 patent ............................................................. 1
`B.
`Background of Nasal Bridles............................................................... 4
`STANDING (37 C.F.R. § 41.104(A)); PROCEDURAL
`STATEMENTS .............................................................................................6
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(A)(1))....................................6
`A.
`Each Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))........................... 6
`B.
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2))............................. 6
`1.
`Judicial Matters ......................................................................... 6
`2.
`Administrative Matters.............................................................. 7
`Designation of Lead and Back-Up Counsel (37 C.F.R.
`§ 42.8(b)(3)) ........................................................................................ 7
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(A)) ..........................................7
`THE ʼ715 PATENT AND CLAIM CONSTRUCTION ................................ 8
`A.
`The ’715 Patent.................................................................................... 8
`B.
`The Priority Date of the ʼ715 Patent .................................................... 9
`C.
`Claim Construction............................................................................ 10
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) AND
`STATE OF THE ART.................................................................................10
`VIII. IDENTIFICATION OF THE CHALLENGE (37 C.F.R. § 42.104(B)).......11
`IX.
`INVALIDITY ANALYSIS .........................................................................12
`A.
`Ground 1: Ballantyne Anticipates Claim 18..................................... 12
`1.
`Disclosure of Ballantyne ......................................................... 14
`2.
`Patentee’s Admissions Regarding its Alleged
`Improvements over the Disclosure of Ballantyne.................... 21
`Anticipation Analysis of Claim 18 .......................................... 22
`3.
`Ground 2: Claim 18 Would Have Been Obvious Over
`Ballantyne Alone............................................................................... 28
`
`B.
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`1.
`2.
`
`The Level of Ordinary Skill in the Pertinent Art..................... 29
`The Scope and Content of the Prior Art .................................. 29
`a)
`State of the Art .............................................................. 29
`The state of the art has been described above. See supra
`Section II(B).................................................................. 29
`Ballantyne ..................................................................... 29
`b)
`Differences Between the Claims and the Prior Art.................. 30
`3.
`Ground 3: Claim 18 Would Have Been Obvious Over
`Ballantyne in View of the ʼ448 Patent ............................................... 40
`1.
`The Scope and Content of the Prior Art .................................. 40
`2.
`Differences Between the Claims and the Prior Art.................. 42
`Ground 4: Claim 18 Would Have Been Obvious Over
`Ballantyne in View of the ʼ199 Patent and the ʼ538 Patent ............... 51
`1.
`The Scope and Content of the Prior Art .................................. 51
`2.
`Differences Between the Claims and the Prior Art.................. 54
`Secondary Considerations of Non-Obviousness................................ 64
`E.
`CONCLUSION ...........................................................................................65
`X.
`XI. CERTIFICATE OF WORD COUNT..........................................................66
`
`C.
`
`D.
`
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`

`

`TABLE OF AUTHORITIES
`
`Page(s)
`
`CASES
`Amneal Pharmaceuticals, LLC v. Supernus Pharmaceuticals, Inc.,
`IPR2013-00368 (Institution Decision, Paper 8) at pp. 12-13 (Dec.
`17, 2013)........................................................................................................... 55
`Applied Medical Technology, Inc. v. Corpak Medsystems, Inc.,
`1:16-cv-02190 (N.D. Ohio)................................................................................. 4
`Boston Sci. Scimed, Inc. v. Cordis Corp.,
`554 F.3d 982 (Fed. Cir. 2009)........................................................................... 28
`Bristol-Myers Squibb Co. v. Ben Venue Labs.,
`246 F.3d 1368 (Fed. Cir. 2001)......................................................................... 55
`Cisco Sys., Inc., et al. v. Crossroads Sys., Inc.,
`IPR2014-01544 (Institution Decision, Paper 9) at pp. 13-14 (April 3,
`2015)................................................................................................................. 10
`
`Constant v. Advanced Micro-Devices, Inc.,
`848 F.2d 1560 (Fed. Cir. 1988)............................................................... 3, 17, 44
`Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2144-46 (2016) .................................................................................. 7
`Dow Jones & Co. v. Ablaise Ltd.,
`606 F.3d 1338 (Fed. Cir. 2010)......................................................................... 26
`Ethicon Endo-Surgery, Inc. v. Covigien AG,
`IPR2015-01274 (Final Written Decision, Paper 25) at p. 18 (Nov. 30,
`2016)........................................................................................................... 46, 54
`
`Genentech, Inc. v. Chiron Corp.,
`112 F.3d 495 (Fed. Cir. 1997)............................................................................. 6
`Graham v. John Deere Co. of Kansas City,
`383 U.S. 1 (1966)........................................................................................ 25, 37
`
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`Hoffmann-La Roche Inc. v. Apotex Inc.,
`748 F.3d 1326 (Fed. Cir. 2014)......................................................................... 55
`In re Fout,
`675 F.2d 297 (C.C.P.A. 1982) ...................................................................... 3, 44
`In re Icon Health and Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007)......................................................................... 45
`In re Kalm,
`378 F.2d 959 (C.C.P.A. 1967) .......................................................................... 28
`In re Keller,
`642 F.2d 413 (Fed. Cir. 1981)..................................................................... 46, 54
`In re Paulson,
`30 F.3d 1475 (Fed. Cir. 1994)....................................................................... 9, 19
`In re Translogic Tech., Inc.,
`504 F.3d 1249 (Fed. Cir. 2007)........................................................................... 7
`Int’l Business Machines Corp. v. Intellectual Ventures I LLC,
`IPR2015-00302 (Institution Decision, Paper 8) at pp. 14-15 (June
`2, 2015)............................................................................................................. 10
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007)................................................................................ 8, 25, 46
`Micron Tech., Inc. v. Board of Trustees of Univ. of Ill.,
`IPR2013-00005 (Institution Decision, Paper 19) at pp. 5-7 (March
`13, 2013)........................................................................................................... 10
`Microsoft Corp. v. Parallel Networks Licensing, LLC,
`IPR2015-00483 (Institution Decision, Paper 10) at p. 15 (July 15,
`2015)................................................................................................................. 10
`Microsoft Corp. v. Parallel Networks Licensing, LLC,
`IPR2015-00486 (Institution Decision, Paper 10) at p. 15 (July 15,
`2015)................................................................................................................. 10
`Newell Cos., Inc. v. Kenney Mfg. Co.,
`864 F.2d 757 (Fed. Cir. 1988)........................................................................... 55
`
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`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2008)......................................................................... 55
`Praxair Distribution, Inc. v. Ino Therapeautics, LLC,
`IPR2015-00889 (Institution Decision, Paper 14) at pp. 5-6 (Sept.
`22, 2015)........................................................................................................... 10
`Praxair Distribution, Inc. v. Ino Therapeautics, LLC,
`IPR2015-00893 (Institution Decision, Paper 14) at p. 5-6 (Sept. 22,
`2015)................................................................................................................. 10
`Whitserve, LLC v. Computer Packages, Inc.,
`694 F.3d 10 (Fed. Cir. 2012)........................................................... 19, 20, 21, 22
`STATUTES
`35 U.S.C. § 102.................................................................................................. 9, 19
`35 U.S.C. §102(b).................................................................................. 7, 11, 37, 47
`35 U.S.C. § 103.................................................................................................. 9, 37
`OTHER AUTHORITIES
`37 C.F.R. § 41.104(A) ............................................................................................. 3
`37 C.F.R. § 42.6(d) .................................................................................................. 8
`37 C.F.R. § 42.8....................................................................................................4-5
`37 C.F.R. § 42.10(b) ................................................................................................ 5
`37 C.F.R. § 42.22(a)................................................................................................. 5
`37 C.F.R. § 42.100(b) .............................................................................................. 7
`37 C.F.R. § 42.104(B).............................................................................................. 8
`37 C.F.R. § 42.106(a)............................................................................................... 3
`
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`EXHIBITS
`
`EXHIBIT 1001 U.S. Patent No. 6,631,715
`
`EXHIBIT 1002 U.S. Patent No. 5,185,005 (“Ballantyne”)
`
`EXHIBIT 1003
`
`“A New Nasal Bridle for Securing Nasoentereal Feeding
`Tubes” by Jeffrey A. Meer
`EXHIBIT 1004 Declaration of Dr. Terry Layton
`
`EXHIBIT 1005
`
`EXHIBIT 1006
`
`“Securing of intermediate duration feeding tubes” by W.
`Frederick McGuirt
`“The bridle: increasing the use of nasoenteric feedings” by
`Albert Barrocas
`EXHIBIT 1007 U.S. Patent No. 4,778,448 (“the ʼ448 patent”)
`
`EXHIBIT 1008 U.S. Patent No. 6,173,199 (“the ʼ199 patent”)
`
`EXHIBIT 1009
`
`Patent Owner’s Initial Infringement Contentions
`
`EXHIBIT 1010
`
`“Feeding Tube Anchor” by Albert Levenson
`
`EXHIBIT 1011 U.S. Patent No. 5,492,538
`
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`

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`I.
`
`INTRODUCTION
`Corpak Medsystems, Inc. and Halyard Health, Inc. (collectively
`
`“Petitioners”) petition for Inter Partes Review (“IPR”) seeking cancellation of
`
`Claim 18 (“challenged claim”) of U.S. Patent No. 6,631,715 to Kirn (“the ʼ715
`
`patent”) (EX1001), which, according to the current records of the USPTO, is
`
`assigned to Applied Medical Technology, Inc. (“AMT” or “Patent Owner”).
`
`II. OVERVIEW
`Description of the ʼ715 patent
`A.
`The ʼ715 patent issued on October 14, 2003 from U.S. Appl. No. 09/939,399
`
`(“the ʼ399 application”), which was filed on August 24, 2001. EX1001, see
`
`EX1004 at ¶ 37. The ʼ399 application claims priority to U.S. Provisional
`
`Application No. 60/230,525, which was filed on September 1, 2000. Id. The ’715
`
`patent has thirty-two claims. See EX1004 at ¶ 38. This Inter Partes Review,
`
`however, is only directed to a single claim, Claim 18, the text of which is
`
`reproduced below:
`
`18. A method of placing and securing at least one tube
`through a nose into a patient comprising:
`inserting the at least one tube into a first or second nare of
`the nose;
`inserting an end portion of a flexible member having a
`magnet attached thereto into a first nare of the nose;
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`inserting a magnetic probe into a second nare of the nose for
`attracting said magnet and said end portion of said flexible
`member;
`removing said probe from the second nare of the nose
`thereby retrieving said end portion of said flexible member
`through the second nare of the nose; and
`snapping the at least one tube into a channel formed in a
`receiver.
`EX1001 at Claim 18; see also EX1004 at ¶ 40.
`At a very high level, Claim 18 is directed to a method of placing a first tube
`
`with a magnetic element into one of the nasal passages of the patient (referred to in
`
`the claim as a “nare”), retrieving the first tube through the second nasal passage by
`
`placing a second tube with a corresponding magnetic element into the second nasal
`
`passage to magnetically mate with the magnetic element on the first tube, and then
`
`guiding the first tube out through the second nasal passage. EX1004 at ¶ 39. The
`
`medical device, to which the method of Claim 18 is directed, is known as a “nasal
`
`bridle system.” Id. Applications of such medical devices include uses as feeding
`
`tubes, nasogastric tubes, and nasotracheal tubes. EX1001 at 1:15-18; EX1002 at
`
`1:5-18 (U.S. Patent No. 5,185,005 to Ballantyne, referred to hereinafter as
`
`“Ballantyne”); EX1003, Jeffrey A. Meer, A New Nasal Bridle for Securing
`
`Nasoentereal Feeding Tubes, 13 J. Parenteral & Enteral Nutrition, 331, 331-33
`
`(1989); see also EX1004 at ¶ 30.
`
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`Claim 18, however, never should have issued in the first place as it is
`
`anticipated and/or rendered obvious by the prior art. EX1004 at ¶ 139. Indeed,
`
`even in the words of the patentee, prior art reference Ballantyne discloses the
`
`invention of Claim 18:
`
`One such method disclosed in U.S. Pat. No. 5,185,005 to
`Ballantyne requires a bridle which is pulled into a nare of
`a patient’s nose, around the posterior nasal septum, and out
`the other nare by a cord attached to the bridle and an
`insertion tool. Specifically, first and second installation
`tools are inserted into the nares of the patient's nose.
`Magnets associated with each tool couple together
`behind the posterior nasal septum.
`EX1001 at 1:15-32 (emphasis added); see also EX1004 at ¶ 51.
`
`As the patentee plainly admits, both the installation of a nasal bridle through
`
`the nose of a patient and the use of magnets to place medical devices, including
`
`nasal bridles—i.e., the subject matter of Claim 18—were known in the art.
`
`Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1570 (Fed. Cir. 1988)
`
`(holding that an applicant’s admissions regarding prior art are binding); In re Fout,
`
`675 F.2d 297, 300, (C.C.P.A. 1982) (“Valid prior art may be created by the
`
`admissions of the parties.”); see also EX1004 at ¶ 51. Accordingly, Petitioners
`
`request cancellation of Claim 18 of the ʼ715 patent.
`
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`Background of Nasal Bridles
`B.
`Petitioners provide the following background surrounding the technology of
`
`interest in order to provide the appropriate context for analyzing Petitioners’
`
`arguments. Petitioners will also refer to the instant section in its analysis of the
`
`Graham factors for obviousness.
`
`Nasal bridles are nothing new, and, in fact, have been used in the medical
`
`care field since at least 1980 to prevent accidental dislodgement of a nasogastric
`
`tube. Jeffrey A. Meer, A New Nasal Bridle for Securing Nasoentereal Feeding
`
`Tubes, 13 J. Parenteral & Enteral Nutrition, 331, 331 (1989) (EX1003); see also
`
`EX1004 at ¶¶ 29-32. Nasogastric tubes are commonly used to deliver medication
`
`and/or nutrition to hospitalized patients. Id. As Meer explained, dislodgement of
`
`nasogastric tubes was common, occurring in as much as one half of patients. Id.
`
`Dislodgement resulted in many issues such as delayed feeding, increased risk of
`
`aspiration, expenditure of health care professionals’ time, and increased hospital
`
`stay time. Id. Indeed, the earliest designs of nasal bridles were difficult to install,
`
`and thus, health care professionals opted for alternative, albeit lesser, means for
`
`securing feeding tubes. Id.
`
`As originally described, a nasal bridle was “a length of material looped
`
`around the patient’s nasal septum and then secured to the feeding tube.” W.
`
`Frederick McGuirt, Securing of intermediate duration feeding tubes, 90
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`Laryngoscope, 2046-2048 (1980) (EX1005); see also EX1004 at ¶¶ 29-32. One of
`
`the earliest methods of installing the nasal bridle involved inserting a flexible tube
`
`into the nare of a patient, extracting the tube from the patient’s mouth, tying
`
`umbilical tape to the catheter, and then removing the catheter from the nostril in
`
`order to pull the tape through the nostril. Id. The catheter is then passed through
`
`the other nare and umbilical tape introduced into the patient’s nasal cavity in the
`
`same, aforementioned manner. Id. The below figures provide an illustration of the
`
`installation of this method of installing a nasal bridle. Id.
`
`Indeed, additional references disclose the installation of a nasal bridle by
`
`introducing the bridle into the patient’s nares, extracting the bridle from the
`
`patient’s mouth, and forming a bridle into a loop ultimately positioned behind the
`
`patient’s nasal septum. EX1006, Albert Barrocas, The bridle: increasing the use of
`
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`nasoenteric feedings. 2 Nutritional Support Servs., 8, 8-10 (1982); EX1003 at
`
`331-33; EX1010, Albert Levenson, Feeding Tube Anchor, 5 Nutritional Support
`
`Servs. 8, 40, 42 (1985); see also EX1004 at ¶¶ 29-32.
`
`III.
`
`STANDING (37 C.F.R. § 41.104(A)); PROCEDURAL STATEMENTS
`Petitioners certify that: (1) the ʼ715 patent is available for IPR; and (2) the
`
`Petitioners are not barred or estopped from requesting IPR of any claim of the ʼ715
`
`patent on the grounds identified herein. This Petition is filed in accordance with 37
`
`C.F.R. § 42.106(a). Concurrently filed herewith are a Power of Attorney for each
`
`Petitioner and an Exhibit List pursuant to § 42.10(b) and § 42.63(e), respectively.
`
`The required fee is paid through an online credit card, and the office is authorized
`
`to charge any fee deficiencies and credit any overpayments to Deposit Acct. No.
`
`160605 (Customer ID No. 00826).
`
`IV. MANDATORY NOTICES (37 C.F.R. § 42.8(A)(1))
`A.
`Each Real Party-in-Interest (37 C.F.R. § 42.8(b)(1))
`The real parties in interest are Halyard Health, Inc., Medsystems Holdings,
`
`Inc., Corpak Medsystems, Inc., and Halyard Sales, LLC.
`
`B.
`
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`1.
`Judicial Matters
`The ʼ715 patent is the current subject of the litigation styled Applied Medical
`
`Technology, Inc. v. Corpak Medsystems, Inc., 1:16-cv-02190 (N.D. Ohio).
`
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`Administrative Matters
`2.
`The Public Patent Application Information Retrieval (“Public PAIR”)
`
`system indicates that the ʼ715 patent issued from the ʼ399 application, which
`
`claims priority to Provisional U.S. Application No. 60/230,535, which was filed on
`
`September 1, 2000. Public PAIR also indicates that U.S. Patent No. 6,837,237,
`
`which issued January 4, 2005, also claims priority to the aforementioned ʼ399
`
`application.
`
`Designation of Lead and Back-Up Counsel (37 C.F.R. § 42.8(b)(3))
`C.
`Lead counsel is Richard M. McDermott (Reg. No. 40,720) and backup
`
`counsel are Jitendra Malik Ph.D. (Reg. No. 55,823) and Tasneem D. Delphry (Reg.
`
`No. 72,506). Please direct all correspondence to lead counsel at the following
`
`address: 101 S. Tryon St, Ste 4000, Charlotte, NC 28280; telephone 704-444-
`
`1000. Pursuant to 37 C.F.R. § 42.10(b), Powers of Attorney are being submitted
`
`with this Petition. Petitioners consent to email service at:
`
`rick.mcdermott@alston.com, jitty.malik@alston.com, and
`
`tasneem.delphry@alston.com. 37 C.F.R. § 42.8(b)(4).
`
`V.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED AND THE
`REASONS THEREFOR (37 C.F.R. § 42.22(a))
`Petitioners request IPR and cancellation of Claim 18. Petitioners’ full
`
`statement of the reasons for the relief requested is set forth in detail below.
`
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`VI. THE ʼ715 PATENT AND CLAIM CONSTRUCTION
`A.
`The ’715 Patent
`The specification of the ʼ715 patent is allegedly directed to “systems for
`
`placing and securing a nasal tube; and more particularly to such a system which
`
`utilizes magnets in the placement of a bridle used in combination with a receiver to
`
`secure the nasal tube.” EX1001 at 1:8-12; see also EX1004 at ¶ 38. In other
`
`words, the ʼ715 patent’s specification purports to describe an apparatus and
`
`corresponding method for use in “placing and securing at least one nasal tube in a
`
`patient.” EX1001 at 2:21-32; see also EX1004 at ¶ 38.
`
`The apparatus described in the specification of the ʼ715 patent is
`
`straightforward: it consists of a “flexible member” with a magnet secured at one
`
`end, another instrument consisting of a “magnetic probe,” and a “receiver.” Id.;
`
`see also EX1004 at ¶ 39. Similarly, the method disclosed in the ʼ715 patent is as
`
`straightforward as the disclosed apparatus. Id. The method described in the
`
`specification requires insertion of the magnetic end of the flexible member into one
`
`nostril and insertion of the magnetic probe into the second nostril so that the
`
`magnets mate. EX1001 at 6:30-46; see also EX1004 at ¶ 39. Once the magnets
`
`have mated, the magnetic probe is withdrawn from the second nostril and the
`
`flexible member is pulled “into the first nare and out through the second nare” and
`
`thus “looped around the nasal septum.” EX1001 at 6:61-66; see also EX1004 at ¶
`
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`39. The magnetic probe and the flexible member are then separated and the end
`
`portions of the flexible member and nasal tube are secured in a receiver. EX1001
`
`at 7:1-14; see also EX1004 at ¶ 39.
`
`Claim 18 recites elements directed to the aforementioned method adding
`
`only the additional limitation that “at least one tube” is “snapp[ed]” into the
`
`receiver. EX1001 at Claim 18; see also EX1004 at ¶ 40. Moreover, the preamble
`
`to Claim 18 includes the transition term “comprising.” EX1001 at Claim 18; see
`
`also EX1004 at ¶ 40. This means that “other elements may be added and still form
`
`a construct within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112
`
`F.3d 495, 501 (Fed. Cir. 1997) (internal quotations and citations omitted).
`
`The Priority Date of the ʼ715 Patent
`B.
`The ʼ715 patent issued from the ʼ399 application, which was filed on August
`
`24, 2001. EX1001. The face of the ʼ715 patent claims priority to U.S. Prov. Appl.
`
`No. 60/230,535, which was filed on September 1, 2000. Id. Patent Owner,
`
`however, has stated in the related patent litigation involving Petitioner Corpak
`
`Medsystems, Inc. that the challenged claim of the ʼ715 patent is entitled to claim
`
`priority only to August 24, 2001, the filing date of the ‘399 application. EX1009,
`
`Patent Owner’s Initial Infringement Contentions at 2; see also EX1004 at ¶ 37. In
`
`any event, as described below, whether the correct priority date is September 1,
`
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`2000 or August 24, 2001, all of the references relied upon by Petitioners qualify as
`
`prior art under 35 U.S.C. §102(b) (pre-AIA). EX1004 at ¶ 37.
`
`Claim Construction
`C.
`In an inter partes review, the Board generally interprets a claim term in an
`
`unexpired patent according to its broadest reasonable construction in light of the
`
`specification of the patent in which it appears. 37 C.F.R. § 42.100(b). In the view
`
`of the Petitioners and their expert, Dr. Layton, the limitations of Claim 18 should
`
`be given their broadest reasonable interpretation in light of the specification of the
`
`ʼ715 patent. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2144-46 (2016); see
`
`also EX1004 at ¶ 36. Under this standard, no terms or phrases require specific
`
`construction. Id. In other words, the claim terms should be given their ordinary
`
`and customary meaning, as would be understood by one of ordinary skill in the art
`
`at the time of the invention, in the context of the entire patent disclosure. In re
`
`Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007); EX1004 at ¶ 36.
`
`VII. PERSON OF ORDINARY SKILL IN THE ART (“POSA”) AND
`STATE OF THE ART
`A POSA is a hypothetical person who is presumed to be aware of all
`
`pertinent art, thinks along conventional wisdom in the art, and is a person of
`
`ordinary creativity. KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 420 (2007); see
`
`also EX1004 at ¶ 33. A POSA of the ʼ715 patent would have had education and/or
`
`experience in the biological sciences, engineering, medical device manufacturing,
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`and/or design along with knowledge of the scientific literature in the field.
`
`EX1004 at ¶¶ 33-34. Although education and experience levels may vary, a POSA
`
`would have had at least a bachelor’s degree in biology, bioengineering, biomedical
`
`engineering, zoology or equivalent. Id.
`
`A POSA also would have had work experience in the field of medical
`
`devices including several years of experience designing fluid administration and/or
`
`fluid collection devices and the attachment mechanisms for the devices including
`
`experience with devices used in nasogastric/nasoenteric intubation and
`
`corresponding attachment systems. EX1004 at ¶¶ 33-34. A person holding only a
`
`bachelor’s degree would be required to have had five years of relevant work
`
`experience to qualify as a POSA, but a person with a more advanced degree, such
`
`as a master’s of science, could qualify as a POSA with fewer years of experience.
`
`Id.
`
`VIII. IDENTIFICATION OF THE CHALLENGE (37 C.F.R. § 42.104(B))
`IPR of Claim 18 of the ʼ715 patent is respectfully requested on the grounds
`
`of unpatentability listed below. Per 37 C.F.R. § 42.6(d), copies of the references
`
`are filed herewith. In support of the proposed grounds for unpatentability, this
`
`Petition includes the declaration of a technical expert, Dr. Terry Layton (EX1004),
`
`explaining what the art would have conveyed to a POSA as of the priority date.
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`Dr. Layton has offered a declaration from the perspective of a POSA as of the
`
`priority date.
`
`Reference(s)
`U.S. Patent No. 5,185,005 (EX1002)
`U.S. Patent No. 5,185,005 (EX1002)
`U.S. Patent No. 5,185,005 (EX1002) in view
`of U.S. Patent No. 4,778,448 (EX1007)
`U.S. Patent No. 5,185,005 (EX1002) in view
`of U.S. Patent No. 6,173,199 (EX1008) and
`U.S. Patent No. 5,492,538 (EX1011)
`
`Basis Claim Challenged
`§ 102
`18
`§ 103
`18
`§ 103
`18
`
`§ 103
`
`18
`
`Other prior art references, in addition to the primary references listed above,
`
`provide further background in the art, further motivation to combine the teachings
`
`of the primary references, and/or further support for why a POSA would have a
`
`reasonable expectation of success in combining the teachings of the primary
`
`references to arrive at the method described in Claim 18. See EX1004 at ¶¶ 29-32.
`
`IX.
`
`INVALIDITY ANALYSIS
`A.
`Ground 1: Ballantyne Anticipates Claim 18
`Anticipation under 35 U.S.C. § 102 requires that each and every element of
`
`the claimed invention be disclosed expressly or inherently in a single prior art
`
`reference. See e.g., In re Paulson, 30 F.3d 1475, 1478-79 (Fed. Cir. 1994).
`
`Ballantyne anticipates Claim 18 of the ʼ715 patent. EX1004 at ¶ 42. Ballantyne,
`
`entitled “Method and Apparatus for Securing a Nasogastric Tube” was filed on
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`June 4, 1991 and issued on February 9, 1993.1 Id. at ¶ 43. Accordingly,
`
`Ballantyne qualifies as a prior art reference to the ’715 patent under 35 U.S.C.
`
`§ 102(b) (pre-AIA). See EX1004 at ¶ 43.
`
`1 Ballantyne was disclosed to the PTO during prosecution of the ’715 patent
`
`but it was not cited in an Office Action or referred to during prosecution. EX1001
`
`(showing Ballatnyne in the “References Cited” on the face of the patent, but not
`
`showing any asterisk notation indicating that the examiner relied upon the
`
`reference). Husky Injection Molding Systems, Ltd. v. Plastic Engineering &
`
`Technical Services, Inc., No. IPR2016-00432, slip op. 6-7 (P.T.A.B. June 24,
`
`2016) (Paper 10) (“Patent Owner has not demonstrated that this particular
`
`combination of references, as formulated by the Petitioner, was ever considered by
`
`the Examiner”). Moreover, the fact a reference was disclosed to the Examiner is
`
`not a bar to institute an IPR. See Praxair Distribution, Inc. v. Ino Therapeautics,
`
`LLC, IPR2015-00893 (Institution Decision, Paper 14) at pp. 7-8 (Sept. 22, 2015);
`
`Praxair Distribution, Inc. v. Ino Therapeautics, LLC, IPR2015-00889 (Institution
`
`Decision, Paper 14) at pp. 9-10 (Sept. 22, 2015); Microsoft Corp. v. Parallel
`
`Networks Licensing, LLC, IPR2015-00483 (Institution Decision, Paper 10) at p. 15
`
`(July 15, 2015); Microsoft Corp. v. Parallel Networks Licensing, LLC, IPR2015-
`
`00486 (Institution Decision, Paper 10) at p. 15 (July 15, 2015); Int’l Business
`
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`Disclosure of Ballantyne
`1.
`The Board and the skilled artisan need go no further than the Abstract of
`
`Ballantyne to see the similarities between Ballantyne and Claim 18 of the ’715
`
`patent:
`
`A nasogastric tube anchor, and a method of its use
`employing a bridle which passes through the patient's
`nostrils and nasopharynx, the ends of the bridle being
`fastened to a nasogastric tube exterior to the patient's nose
`to anchor said tube against undesired movement relative
`to the patient's nostril. Installation tools and methods are
`provided for positioning said bridle within the patient's
`nose such that one end of the bridle extends from each
`nostril.
`EX1002 at Abstract; see also EX1004 at ¶ 44.
`
`Much like Claim 18 of the ’715 patent, Ballantyne teaches a method for
`
`anchoring a nasogastric tube by inserting a nasal bridle into one nostril, through the
`
`Machines Corp. v. Intellectual Ventures I LLC, IPR2015-00302 (Institution
`
`Decision, Paper 8) at pp. 14-15 (June 2, 2015); Cisco Sys., Inc., et al. v.
`
`Crossroads Sys., Inc., IPR2014-01544 (Institution Decision, Paper 9) at pp. 13-14
`
`(April 3, 2015).
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`nasopharynx and beyond the nasal septum, and drawing the tube out of the other
`
`nostril. EX1002, Abstract at 2:20-32; see also EX1004 at ¶¶ 44-45. Figure 2 of
`
`Ballantyne, reproduced below, further illustrates the teachings of Ballantyne:
`
`EX1002 at Fig. 2; EX1004 at ¶ 45.
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`Ballantyne describes the method of placing its bridle devices in the nasal
`
`passages by primarily referring to Figures 3 and 6 (reproduced below):
`
`EX1002 at Figs. 3, 6; EX1004 at ¶¶ 46-47.
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`In reference to these figures, “[f]irst installation tool 34 comprises an
`
`adequately rigid tube sized to be slidable over bridle member 10, yet narrow
`
`enough to be easily insertable into a nostril such that the distal end 68 of first
`
`installation assembly 32 resides within the nasopharynx beyond the posterior nasal
`
`septum.” EX1002 at 5:63-6:1; EX1004 at ¶ 47. Ballantyne further teaches that:
`
`Referring to FIGS. 3 and 4, in a preferred embodiment,
`bridle 10 is installed in a patient's nose by a method
`comprising inserting the distal end 68 of
`first
`installation assembly 32 into a first nostril of the patient
`until magnetic member 40 is positioned beyond the
`posterior nasal septum. The distal end 66 of second
`installation assembly 56 is then inserted into a second
`nostril of the patient unt